SpaceOAR System— 510(k) K181465

Substantially Equivalent

Augmenix, Inc.

FDA 510(k) clearance K181465 for SpaceOAR System, Substantially Equivalent on 2018-06-25. Applicant: Augmenix, Inc..

Clearance details

Applicant: Augmenix, Inc.
Product code: Code OVB
Advisory panel: Radiology
Date received: 2018-06-04
Decision date: 2018-06-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVB

product code OVB

Death: 7
Injury: 658
Malfunction: 1,206
Total: 1,871

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.